ColciGel (colchicinum 4X)

ColciGel (colchicinum 4X) transdermal gel is an alkaloid indicated for treatment and prophylaxis of gout flares in adults. ColciGel is not an analgesic medication and should not be used to treat pain from other causes.

Common side effects of ColciGel include:

• mild skin irritation at the site of application

Children under 16 years of age do not use unless directed by a physician.

DISCARD 6 MONTHS AFTER FIRST USE

• ColciGel (Colchicinum 4X) is a substrate of the efflux transporter P-glycoprotein (P-gp).
• Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicinum.
• If ORAL colchicine is administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicinum are likely.
• Fatal drug interactions have been reported.
• Topical application of ColciGel has demonstrated insignificant systemic absorption in animal testing and confirmed in limited human pharmacokinetic evaluations and, therefore, poses a limited risk of clinically significant drug interactions.
• Physicians should, however, ensure that patients are suitable candidates for treatment with ColciGel and remain alert for signs and symptoms of toxicities related to increased colchicinum exposure as a result of a drug interaction.
• Signs and symptoms of ColciGel toxicity should be evaluated promptly and, if toxicity is suspected, ColciGel should be discontinued immediately.

• No human or animal studies on the effect of ColciGel® (colchicinum 4X) in pregnancy have been conducted.
• It is not known whether ColciGel (colchicinum 4X) is excreted in breast milk.